Staging preview: health content pending qualified review
D2C Peptides

Profile

What is ARA-290?

ARA-290 (cibinetide) is an experimental 11-amino-acid peptide copied from one face of erythropoietin (EPO), the hormone that drives red blood cell production.12 It was designed to keep EPO's tissue-protective signal without that red cell effect.2 It has been tested in people only in a few small, short studies and is not an approved medicine.34

This page summarizes published sources for information only. It is not medical advice and does not tell anyone to use a product. Questions about your own health belong with a licensed clinician. For questions about an order or a product, contact us.

Key facts

ClassSynthetic 11-amino-acid peptide modeled on EPO; described as an innate repair receptor agonist; it did not stimulate red blood cell production in lab and animal tests256
Also known asCibinetide (INN and USAN), ARA 290, ARA290, pHBSP (pyroglutamate helix B surface peptide); FDA UNII 9W5677JKDA17
Forms we sellOne 10 mg vial of freeze-dried powder, labeled for research use only
Regulatory statusNot an approved medicine; four FDA and two EU orphan designations, none a marketing approval; FDA 503A category 3 for compounding4689
WADA statusNot named, but its class, innate repair receptor agonists, is prohibited at all times under S2.1.5 of the 2026 List10611

What sources report

ARA-290 was engineered from the three-dimensional structure of EPO by Michael Brines, Anthony Cerami and colleagues, and described in PNAS in 2008.2 It copies the aqueous, or water-facing, surface of EPO's helix B.2 Its first amino acid, glutamine, closes into a ring called pyroglutamate, which gives the name pHBSP.2 Araim Pharmaceuticals of New York developed it as ARA 290 and sponsored its FDA orphan designations.412 For lab work, the compound is listed as ARA-290 for sale in a freeze-dried research vial.

How it is thought to work

The developers propose that ARA-290 acts on an innate repair receptor, a pairing of the EPO receptor with the beta-common receptor (CD131).5 Their 2016 review says this receptor is usually absent from normal tissue and is switched on locally by injury, low oxygen or metabolic stress.5 EMA's summary says that, once activated, the receptor blocks the production of inflammatory messengers (cytokines), and that these actions are expected to reduce inflammation.6

The evidence for that model points two ways. In a nerve-injury pain model, ARA-290 relieved pain from light touch or cold in rats and normal mice, but not in mice lacking the beta-common receptor.26 An independent 2018 biophysical study, however, found that the outer regions of the two receptors did not bind each other directly, with or without EPO or ARA-290, and noted that the model is controversial.27

The peptide leaves the blood fast: in people, its elimination half-life is about 20 minutes after an injection under the skin and about 2 minutes after an intravenous one.5 Its effects can outlast it, since in rats pain relief lasted as long as 15 weeks, even when treatment stopped after five doses.26

What human studies show

Study People Design Main result
Sarcoidosis pilot (2012) 22 patients with neuropathy symptoms Double blind, intravenous, 4 weeks Symptom score (SFNSL) fell 11.5 points against 2.9 on placebo (p < 0.05); pain and fatigue improved equally in both groups15
Sarcoidosis trial (2013) 38 adults with small nerve fiber loss Double blind, under the skin, 28 days Corneal nerve fiber area rose 14.5% (p = 0.022) against a 5.3% fall on placebo; 6-minute walk rose 18.7 m against a 15.1 m drop (p = 0.049); pain fell about 9% in both groups16
Sarcoidosis phase 2b (2017) 64 patients with nerve fiber loss and pain Randomized, three doses against placebo, 28 days Only the 4 mg group gained corneal nerve fiber area over placebo (697 square micrometers, P = 0.012) and regenerating skin nerve fibers (P = 0.035); pain improved in all groups, placebo included17
Type 2 diabetes (2015) 48 adults with painful neuropathy Placebo controlled, 28 days, then 28 days of follow-up HbA1c fell 0.21 points by day 56 against a 0.21 rise on placebo (p = 0.002); lipids and PainDetect scores improved; corneal nerve gains only in a post hoc subgroup2122
Diabetic macular edema (2020) 9 adults Open label, single arm, 12 weeks No gain in visual acuity (-2.9 letters) or retinal thickness (+10 microns); vision quality-of-life score up 2.7 points23
Healthy volunteers (2015) 36 adults Double blind, one intravenous dose No effect on mood a week later; mixed effects on emotional processing2435
Jaw nerve injury case series (2026) 3 patients Uncontrolled, 4 weeks, given with TB-500, BPC-157, dexamethasone and a local anesthetic Sensory problems decreased in all three; the effect of ARA-290 alone cannot be judged25

Most of these trials were funded by or run with the developer, whose officers co-authored the papers and owned stock.235 The corneal and skin nerve counts are surrogate markers from short, small trials, and no trial lasted beyond 12 weeks or reached phase 3.16173

Lab and animal findings

  • Rodent injury models (2008): the peptide, studied as pHBSP, gave benefit in models of stroke and of kidney injury after interrupted blood flow, sped wound healing and improved cognitive function.2
  • Diabetic rats (2016): 4 weeks of daily dosing lowered blood glucose after 3 and 4 weeks, cut HbA1c by about 20% and raised glucose-stimulated insulin release from their islets, without changing hematocrit.18
  • Aging rats (2022): treatment from 18 months of age for 15 months preserved heart pumping function, limited the rise in blood pressure and lowered frailty scores, but median lifespan and overall survival did not differ from saline (P = 0.182).28

These are animal results, not evidence of the same effects in people.

What has not been studied

No human trial has tested ARA-290 for wound, tendon, muscle or sports injury healing.16172 It has not been tested for weight loss: the diabetes trial measured safety, HbA1c and nerve symptoms, not weight.22 Human data on mood and thinking come from one single-dose study, and no trial has tested memory, focus or cognitive decline.242 There are no human data on aging.28 Related goal pages: Peptides and healing and recovery, Peptides and blood sugar, Peptides and focus and memory and Peptides and weight loss.

How it compares with EPO and other peptides

Epoetin alfa, an EPO medicine for anemia such as in chronic kidney failure, makes the bone marrow produce more red blood cells, and MedlinePlus lists risks of blood clots, stroke, serious heart problems and shorter survival in some people with cancer.29 ARA-290 was designed not to raise red blood cells, but its long-term heart and cancer-related safety has not been studied.519 WADA names carbamylated and asialo EPO as examples of innate repair receptor agonists, the class ARA-290 is described as belonging to.105

ARA-290 is a different molecule from BPC-157 and TB-500, which the 2026 case series gave together with it.25 See What is BPC-157? and What is TB-500?.

Side effects

Multi-dose safety data come from trials lasting 28 days to 12 weeks in groups of 9 to 64 people, so long-term safety is unknown.52317 No approved label exists, so there is no official list of interactions, contraindications or warnings.412

Mild and common events

  • Phase 2b sarcoidosis trial, registry results: headache in 8 of 46 people on ARA-290 and 0 of 16 on placebo, nausea in 5 of 46 against 0 of 16, and fatigue in 5 of 46 against 2 of 16.31 Injection-site pain affected 3 of 46 on ARA-290 and 4 of 16 on placebo.31
  • Macular edema trial, 12 weeks: all 9 people had at least one adverse event, none serious.23 The most frequent were raised triglycerides (5 of 9), headache (4 of 9), head cold (4 of 9), raised glucose (3 of 9) and nausea (2 of 9).23 Investigators judged headache, head cold and nausea potentially drug related.23
  • Type 2 diabetes trial, 28 days: event counts were similar between groups, with 54 mild, 9 moderate and 1 severe on ARA-290, against 61 mild and 5 moderate on placebo.22
  • Sarcoidosis trials of 22 and 38 people: the intravenous pilot recorded no adverse events.19 The 28-day trial had no serious events and no injection-site pain or irritation.16

Serious events

  • Phase 2b trial: serious events affected 2 of 16 people on 1 mg (fainting, headache, chest tightness, shortness of breath and small bowel inflammation were listed), 1 of 14 on 8 mg (suicidal thoughts), and none on 4 mg or placebo.31 The registry does not say whether these were drug related.31
  • Type 2 diabetes trial: 4 serious events occurred in the ARA-290 arm, and 2 were judged possibly related.22 One was worsening of borderline kidney function (creatinine 119 to 159 micromol/L) in a patient whose furosemide dose had been raised, and the drug was stopped.22 A fatal heart attack after severe cellulitis, 2 weeks after the last dose, was judged unrelated.22
  • Mood: the 2020 macular edema report notes that 1 person with past depression, out of over 200 treated with cibinetide, had suicidal thoughts while using it.23 That trial screened for suicidal thoughts and found none.23

Antibodies and blood counts

  • No antibodies against ARA-290 were detected in the 28-day sarcoidosis trial, the 28-day diabetes trial or the 12-week macular edema trial.162223
  • Hemoglobin did not change in the 4-week intravenous trial (8.9 to 8.7 mmol/L on ARA-290, 8.6 to 8.7 on placebo), and the diabetes trial found no clinically significant changes in blood counts.1922

Trial drug was a sterile preparation made for the studies, so these safety data do not describe research-market vials.22

Dosage information

No dose of ARA-290 is approved or established for any human use, and no trial has reached phase 3.43 The doses below come from small, short research studies. They describe what study participants received and are not guidance for any person.5

Study People Route and dose Schedule
Sarcoidosis pilot (2012) 12 on ARA-290, 10 on placebo 2 mg intravenously Three times weekly for 4 weeks15
Sarcoidosis trial (2013) 21 on ARA-290, 17 on placebo 4 mg under the skin Once daily for 28 days16
Sarcoidosis phase 2b (2017, NCT02039687) 64 in four groups 1, 4 or 8 mg under the skin, or 1 mL placebo Once daily for 28 days3117
Type 2 diabetes (2015) 48, 24 per group 4 mg under the skin, self-injected Once daily for 28 days, then 28 days without treatment2122
Diabetic macular edema (2020, NCT06626971) 9 4 mg under the skin, self-given Once daily for 12 weeks2320
Healthy volunteers (2015, NCT02070783) 36 2 mg intravenously One dose2435
Prediabetes or type 2 diabetes (NCT01933529) Registry record only 4.0 mg under the skin Every morning for 28 days; no results posted32
Jaw nerve case series (2026) 3 4 mg inside the mouth, combined with other drugs Weekly for 4 weeks25

The 4 mg dose under the skin was chosen after a crossover study in 10 healthy volunteers compared the earlier 2 mg intravenous dose with 2, 4 or 6 mg under the skin.16

Rat studies used 30 micrograms per kg into the abdomen for nerve pain, 30 micrograms per kg under the skin daily for 4 weeks in diabetic rats, and 100 micrograms per kg into the abdomen three times a week for 15 months in aging rats.261828 These animal figures are not a basis for any human dose. General background is in Peptide dosage basics.

Reconstitution and storage

ARA-290 has no approved label, so no official instructions exist for reconstituting it, storing it or judging its stability.412 In the lab, enzymes in blood plasma and serum broke ARA-290 down extensively, leaving one main fragment, PyrEQLERALN.11 Storage figures for the vial sold here come from the supplier and appear on its product page. General lab handling, from sterile technique to concentration math, is in How to reconstitute a peptide vial, the reconstitution calculator and How to store peptides.

Regulatory status

United States: ARA-290 is not an approved medicine and has no brand name or prescription label.412 FDA's orphan drug database lists four designations, all sponsored by Araim Pharmaceuticals and all marked "Not FDA Approved for Orphan Indication": delayed graft function after kidney transplant (September 18, 2009), neuropathic pain in sarcoidosis (September 13, 2011), sarcoidosis (June 13, 2016), and survival and function of pancreatic islets after transplant (June 13, 2016).1341214

Compounding: FDA's 503A list updated May 14, 2026 places cibinetide (ARA-290) in category 3, substances nominated without adequate support.9 FDA says category 3 substances are not eligible for the policy that applies to category 1, and that it would consider taking action against a compounder who uses them.33 ARA-290 is not on FDA's page of bulk substances that may present significant safety risks.30 In a March 2026 letter to a research-peptide seller, FDA said the firm's website showed its products were intended to be drugs for human use, despite "Research Use Only" labels.34

Europe: the European Commission granted orphan designations for sarcoidosis (EU/3/13/1191, 7 October 2013) and for preventing graft loss in pancreatic islet transplantation (EU/3/16/1721, 29 August 2016).68 Both showed the status "Positive" when checked in October 2026, and sponsorship moved to Araim Pharmaceuticals Europe Limited, Ireland, in April 2019.68 An orphan designation is not a marketing approval.6

Development and sport: ClinicalTrials.gov lists four ARA 290 studies, none in phase 3: two completed, one of unknown status, and one terminated because the study drug expired with no replacement available.320 No current statement from the developer about its plans was found for this page. Under the 2026 WADA List, its class, innate repair receptor agonists, is prohibited at all times (S2.1.5).106

ARA-290 in the store

ARA-290 for sale: strengths, stock and shipping are on the product page.

For research use only. Not for human or veterinary use. Read the research use policy.

Related reading

Related profiles

Frequently asked questions

Is ARA-290 the same as cibinetide?

Yes. Cibinetide is the official nonproprietary name, listed as both the INN and the USAN, for the peptide developed under the code ARA 290.7 It is also called pHBSP, short for pyroglutamate helix B surface peptide, and PubChem files it as CID 91810664 with CAS number 1208243-50-8.12

Is ARA-290 FDA approved?

No. FDA's orphan drug database lists four orphan designations for it, covering sarcoidosis, neuropathic pain in sarcoidosis, delayed graft function after kidney transplant and pancreatic islet survival after transplant, and marks each one 'Not FDA Approved for Orphan Indication'.4121314 An orphan designation is not an approval. No ARA-290 trial has reached phase 3, and no prescription label exists.34

Does ARA-290 work for neuropathy or nerve pain?

The evidence is small and mixed. In 4-week sarcoidosis trials, symptom questionnaires improved more than on placebo (22 and 38 people), and corneal nerve fiber area rose at 4 mg a day (38 and 64 people).151617 Average pain intensity, however, improved about as much on placebo.151617 In a 48-person type 2 diabetes trial, neuropathy scores improved more than on placebo.2122 No larger or longer trial has confirmed these results.3

Does ARA-290 raise red blood cells like EPO?

It was designed not to. In the 2008 lab and animal studies that described it, the peptide did not stimulate red blood cell production.2 Diabetic rats given it daily for 4 weeks showed no change in hematocrit, and in a 4-week trial in people with sarcoidosis, hemoglobin stayed level against placebo.1819 Effects of longer use in people have not been studied.5

Is ARA-290 banned in sports?

It falls in a banned class. The 2026 WADA Prohibited List bans innate repair receptor agonists at all times, in and out of competition, under class S2.1.5, and the ban is not limited to the examples it names.10 EMA describes ARA-290 as activating the innate repair receptor, and anti-doping scientists in Cologne called it a prohibited peptide in 2017.611 Athletes can confirm its status with their anti-doping organization.

Written by D2C Peptides Editorial Team.

Pending qualified review.

Updated .

Sources

  1. Cibinetide: depositor-supplied synonyms (PubChem CID 91810664). PubChem, National Center for Biotechnology Information (NIH/NLM), 2026.
  2. Nonerythropoietic, tissue-protective peptides derived from the tertiary structure of erythropoietin (Brines M, Patel NSA, Villa P, et al.). Proceedings of the National Academy of Sciences of the USA (PNAS), via PubMed Central, 2008.
  3. ClinicalTrials.gov search: studies with intervention ARA 290, cibinetide or ARA290. ClinicalTrials.gov, U.S. National Library of Medicine, 2026.
  4. Orphan designation record: L-pyr-L-glu-L-gln-L-leu-L-glu-L-arg-L-ala-L-leu-L-asn-L-ser-L-ser, treatment of neuropathic pain in patients with sarcoidosis. U.S. Food and Drug Administration, Search Orphan Drug Designations and Approvals, 2011.
  5. Targeting the innate repair receptor to treat neuropathy (Dahan A, Brines M, Niesters M, Cerami A, van Velzen M). Pain Reports, via PubMed Central, 2016.
  6. EU/3/13/1191: orphan designation for treatment of sarcoidosis (cibinetide). European Medicines Agency, 2013.
  7. UNII 9W5677JKDA: CIBINETIDE (UNII substance record). U.S. Food and Drug Administration, Global Substance Registration System (precisionFDA UNII search), 2026.
  8. EU/3/16/1721: orphan designation for prevention of graft loss in pancreatic islet transplantation (cibinetide). European Medicines Agency, 2016.
  9. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (updated May 14, 2026). U.S. Food and Drug Administration, 2026.
  10. Doping agent classes and substances 2026 (Prohibited Substances and Methods in Sports 2026, based on the WADA Prohibited List). Finnish Center for Integrity in Sports (SUEK), Finland's national anti-doping organization, 2026.
  11. Characterization of in vitro generated metabolites of selected peptides <2 kDa prohibited in sports (Thomas A, Knoop A, Schänzer W, Thevis M; PubMed abstract). Drug Testing and Analysis, via NCBI PubMed (E-utilities), 2017.
  12. Orphan designation record: L-pyr-L-glu-L-gln-L-leu-L-glu-L-arg-L-ala-L-leu-L-asn-L-ser-L-ser, treatment of sarcoidosis. U.S. Food and Drug Administration, Search Orphan Drug Designations and Approvals, 2016.
  13. Orphan designation record: L-pyr-L-glu-L-gln-L-leu-L-glu-L-arg-L-ala-L-leu-L-asn-L-ser-L-ser, prevention of delayed graft function following renal transplant. U.S. Food and Drug Administration, Search Orphan Drug Designations and Approvals, 2009.
  14. Orphan designation record: L-pyr-L-glu-L-gln-L-leu-L-glu-L-arg-L-ala-L-leu-L-asn-L-ser-L-ser, pancreatic islets following transplantation. U.S. Food and Drug Administration, Search Orphan Drug Designations and Approvals, 2016.
  15. Safety and efficacy of ARA 290 in sarcoidosis patients with symptoms of small fiber neuropathy: a randomized, double-blind pilot study (PubMed abstract, PMID 23168581). Molecular Medicine, via NCBI PubMed (E-utilities), 2012.
  16. ARA 290 improves symptoms in patients with sarcoidosis-associated small nerve fiber loss and increases corneal nerve fiber density (Dahan A, et al.; full text). Molecular Medicine, via PubMed Central, 2013.
  17. Cibinetide improves corneal nerve fiber abundance in patients with sarcoidosis-associated small nerve fiber loss and neuropathic pain (Culver DA, et al.; PubMed abstract, PMID 28475703). Investigative Ophthalmology & Visual Science, via NCBI PubMed (E-utilities), 2017.
  18. ARA290 Improves Insulin Release and Glucose Tolerance in Type 2 Diabetic Goto-Kakizaki Rats (Muller C, et al.). Molecular Medicine, via PubMed Central, 2016.
  19. Safety and efficacy of ARA 290 in sarcoidosis patients with symptoms of small fiber neuropathy: a randomized, double-blind pilot study (Heij L, et al.; full text). Molecular Medicine, via PubMed Central, 2012.
  20. The Use of ARA290 for the Treatment of Diabetic Macular Oedema (NCT06626971). ClinicalTrials.gov, U.S. National Library of Medicine, 2024.
  21. ARA 290, a nonerythropoietic peptide engineered from erythropoietin, improves metabolic control and neuropathic symptoms in patients with type 2 diabetes (PubMed abstract, PMID 25387363). Molecular Medicine, via NCBI PubMed (E-utilities), 2015.
  22. ARA 290, a nonerythropoietic peptide engineered from erythropoietin, improves metabolic control and neuropathic symptoms in patients with type 2 diabetes (Brines M, et al.; full text). Molecular Medicine, via PubMed Central, 2015.
  23. A Phase 2 Clinical Trial on the Use of Cibinetide for the Treatment of Diabetic Macular Edema (Lois N, et al.; full text). Journal of Clinical Medicine, via PubMed Central, 2020.
  24. Testing the antidepressant properties of the peptide ARA290 in a human neuropsychological model of drug action (Cerit H, et al.; PubMed abstract, PMID 26431906). European Neuropsychopharmacology, via NCBI PubMed (E-utilities), 2015.
  25. Case Report: Regenerative peptides for inferior alveolar nerve injury: a narrative review with hypothesis-generating three clinical cases. Frontiers in Oral Health, via PubMed Central, 2026.
  26. ARA290, a peptide derived from the tertiary structure of erythropoietin, produces long-term relief of neuropathic pain: an experimental study in rats and β-common receptor knockout mice (Swartjes M, et al.; PubMed abstract, PMID 21873879). Anesthesiology, via NCBI PubMed (E-utilities), 2011.
  27. EPO does not promote interaction between the erythropoietin and beta-common receptors (Cheung Tung Shing KS, et al.). Scientific Reports, via PubMed Central, 2018.
  28. A small erythropoietin derived non-hematopoietic peptide reduces cardiac inflammation, attenuates age associated declines in heart function and prolongs healthspan. Frontiers in Cardiovascular Medicine, via PubMed Central, 2022.
  29. Epoetin Alfa Injection. MedlinePlus, U.S. National Library of Medicine, 2019.
  30. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. U.S. Food and Drug Administration, 2026.
  31. Study of Efficacy of ARA 290 on Corneal Nerve Fiber Density and Neuropathic Symptoms of Subjects With Sarcoidosis (NCT02039687), record with posted results. ClinicalTrials.gov, U.S. National Library of Medicine, 2017.
  32. ARA290 in T2D (Effects of ARA 290, an Erythropoietin Analogue) in Prediabetes and Type 2 Diabetes (NCT01933529). ClinicalTrials.gov, U.S. National Library of Medicine, 2015.
  33. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act. U.S. Food and Drug Administration, 2026.
  34. Warning Letter: Gram Peptides (MARCS-CMS 721806), March 31, 2026. U.S. Food and Drug Administration, 2026.
  35. Cognitive and Neural Effects of ARA290 (NCT02070783). ClinicalTrials.gov, U.S. National Library of Medicine, 2014.